Bioethics: Alzheimer’s Drug Poses a Dilemma for the F.D.A.

Sunday, June 6, 2021

Alzheimer’s Drug Poses a Dilemma for the F.D.A.

If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.

https://www.nytimes.com/2021/06/05/health/alzheimers-aducanumab-fda.html?smid=em-share

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TEXTS Spring 2024

BIOETHICS: THE BASICS (Campbell) ”the word ‘bioethics’ just means the ethics of life”... BEYOND BIOETHICS (Obasogie) “Bioethics’ traditional emphasis on individual interests such as doctor-patient relationships, informed consent, and personal autonomy is minimally helpful in confronting the social and political challenges posed by new human biotechnologies”... THE PREMONITION (Lewis) "The characters you will meet in these pages are as fascinating as they are unexpected. A thirteen-year-old girl’s science project on transmission of an airborne pathogen develops into a very grown-up model of disease control. A local public-health officer uses her worm’s-eye view to see what the CDC misses, and reveals great truths about American society"... WHAT WE OWE THE FUTURE (MacAskill) "argues for longtermism: that positively influencing the distant future is our time’s key moral priority. It’s not enough to reverse climate change or avert a pandemic. We must ensure that civilization would rebound if it collapsed; counter the end of moral progress; and prepare for a planet where the smartest beings are digital. If we make wise choices now, our grandchildren will thrive, knowing we did everything we could to give them a world full of justice, hope and beauty"...

Some past texts

Autism in novels...

On Immunity: An Innoculation (Biss) “If we imagine the action of a vaccine not just in terms of how it affects a single body, but also in terms of how it affects the collective body of a community, it is fair to think of vaccination as a kind of banking of immunity.”

Gratitude (Oliver Sacks) “Oliver Sacks was like no other clinician, or writer. He was drawn to the homes of the sick, the institutions of the most frail and disabled, the company of the unusual and the ‘abnormal.’ He wanted to see humanity in its many variants and to do so in his own, almost anachronistic way—face to face, over time, away from our burgeoning apparatus of computers and algorithms. And, through his writing, he showed us what he saw.” -Atul Gawande, author of Being Mortal

Being Mortal: Medicine and What Matters in the End (Gawande) “We’ve been wrong about what our job is in medicine. We think it is to ensure health and survival. But really it is to enable well-being. And well-being is about the reasons one wishes to be alive.”

Bioethics-pick a chapter (Singer & Kuhse)

Bioethics: Principles, Issues, and Cases-pick a chapter (Vaughn, 2d ed)

Brave New Bioethics (Pence)-"These short pieces range widely over topics including reproductive and therapeutic cloning, assisted reproduction, organ donation, assisted suicide, genetically modified foods and public health care costs. Pence contends that the media have often misrepresented human cloning by reporting that it would produce an identical person to the donor. In fact, he argues, a human clone can never be an exact copy of the donor because the clone will grow up in different social and parenting environments. Pence also argues for lifting the ban on federally funded fertility research on embryos to benefit infertile couples for whom in vitro fertilization is too expensive..."

The Case Against Perfection: Ethics in the Age of Genetic Engineering (Sandel) “When science moves faster than moral understanding, as it does today, men and women struggle to articulate their unease…”

The Cosmic Serpent: DNA and the Origins of Knowledge (Narby) "This adventure in science and imagination, which the Medical Tribune said might herald 'a Copernican revolution for the life sciences,' leads the reader through unexplored jungles and uncharted aspects of mind to the heart of knowledge..."

The Echo Maker (Richard Powers, fiction) "Following a near-fatal accident, Mark Schluter is nursed by his reluctant sister. But when he emerges from his coma, Mark believes that this woman – who looks, acts, and sounds just like his sister – is really an identical impostor. As a famous neurologist investigates his condition, Mark tries to learn what really happened the night of his accident..."

Enough: Staying Human in an Engineered Age (McKibben)-"Reporting from the frontiers of genetic research, nanotechnology and robotics, he explores that subtle moral and spiritual boundary that he calls the "enough point." Presenting an overview of what is or may soon be possible, McKibben contends that there is no boundary to human ambition or desire or to what our very inventions may make possible. In an absorbing and horrifying montage of images, he depicts microscopic nanobots consuming the world and children born so genetically enhanced that they will never be able to believe that they reach for the stars as pianists or painters or long-distance runners because there is something unique in them that has a passion to try..."

Ethics at the End of Life (Oxford Handbook of)-"This handbook explores the topic of death and dying from the late twentieth to the early twenty-first centuries, with particular emphasis on the United States. In this period, technology has radically changed medical practices and the way we die as structures of power have been reshaped by the rights claims of African Americans, women, gays, students, and, most relevant here, patients. Respecting patients' values has been recognized as the essential moral component of clinical decision-making. Technology's promise has been seen to have a dark side: it prolongs the dying process..."

Every Third Thought: On Life, Death, and the Endgame (McCrum) "This is a deeply personal book of reflection and conversation – with brain surgeons, psychologists, hospice workers and patients, writers and poets, and it confronts an existential question: in a world where we have learnt to live well at ..."

The Handmaid's Tale (Margaret Atwood)

Human Enhancement (Savulescu and Bostrom)

Oryx and Crake (Margaret Atwood, fiction) "...an unforgettable love story and a compelling vision of the future. Snowman, known as Jimmy before mankind was overwhelmed by a plague, is struggling to survive in a world where he may be the last human, and mourning the loss of his best friend, Crake, and the beautiful and elusive Oryx whom they both love."

The Politics of Life Itself: Biomedicine, Power, and Subjectivity in ther 21st Century (Rose) "offers a much-needed examination of recent developments in the life sciences and biomedicine that have led to the widespread politicization of medicine, human life, and biotechnology."

Superintelligence: Paths, Dangers, Strategies (Bostrom)

Patient H.M. : A Story of Memory, Madness, and Family Secrets (Dittrich) “Oliver Sacks meets Stephen King”* in this propulsive, haunting journey into the life of the most studied human research subject of all time, the amnesic known as Patient H.M., a man who forever altered our understanding of how memory works—and whose treatment raises deeply unsettling questions about the human cost of scientific progress."

The Checklist Manifesto: How to Get Things Right(Gawande) "The modern world has given us stupendous know-how. Yet avoidable failures continue to plague us in health care, government, the law, the financial industry—in almost every realm of organized activity. And the reason is simple: the volume and complexity of knowledge today has exceeded our ability as individuals to properly deliver it to people—consistently, correctly, safely. We train longer, specialize more, use ever-advancing technologies, and still we fail."

Ordinarily Well: The Case for Antidepressants (Peter Kramer)

The Gene: An Intimate History (Mukherjee)

Generosity (Richard Powers, fiction) A young woman's extraordinary capacity for cheer prompts a geneticist and advocate for genomic enhancement (a la Craig Venter) to exploit her and "announce the genotype for happiness."

The Emperor of All Maladies: A Biography of Cancer (Mukherjee)

The Art of Aging: A Doctor's Prescription for Well-Being (Nuland)

How We Die: Reflections on Life's Final Chapter (Nuland)

How We Live (Nuland)

Humanity Enhanced: Genetic Choice and the Challenge for Liberal Democracies (Russell Blackford)-". Some see the possibility of genetic choice as challenging the values of liberal democracy. Blackford argues that the challenge is not, as commonly supposed, the urgent need for a strict regulatory action. Rather, the challenge is that fear of these technologies has created an atmosphere in which liberal tolerance itself is threatened. Focusing on reproductive cloning, pre-implantation genetic diagnosis of embryos, and genetic engineering, Blackford takes on objections to enhancement technologies..."

The Immortal Life of Henrietta Lacks (Skloot)

Orfeo (Richard Powers, fiction) "Composer Peter Els opens the door one evening to find the police on his doorstep. His home microbiology lab - the latest experiment in his lifelong attempt to find music in surprising patterns - has aroused the suspicions of Homeland Security... an Internet-fueled hysteria erupts..."

Principles of Biomedical Ethics-pick a chapter (Beauchamp & Childress)

Well and Good: A Case Study Approach to Health Care Ethics (Thomas et al)-"presents a combination of classic and little-known cases in health care ethics. These cases, accompanied by information about the major ethical theories, give students a chance to grapple with the ethical challenges faced by health care practitioners, policy makers, and recipients... includes an expanded discussion of feminist ethics, as well as new cases addressing pandemic ethics, humanitarian aid, the social determinants of health, research and Aboriginal communities, and a number of other emerging issues."

From Here to Eternity: Traveling the World to Find the Good Death (Caitlin Doughty)-see "Dead Weight" in links...

The River of Consciousness (Oliver Sacks)-The River of Consciousness is one of two books Sacks was working on up to his death, and it reveals his ability to make unexpected connections, his sheer joy in knowledge, and his unceasing, timeless project to understand what makes us ...

Polio: An American Story (Oshinsky)-"the gripping story of the polio terror and of the intense effort to find a cure, from the March of Dimes to the discovery of the Salk and Sabin vaccines"

Animal Rights: A Very Short Introduction

Medical Ethics: A Very Short Introduction

Life 3.0: Being Human in the Age of Artificial Intelligence (Tegmark)-“All of us—not only scientists, industrialists and generals—should ask ourselves what can we do now to improve the chances of reaping the benefits of future AI and avoiding the risks. This is the most important conversation of our time, and Tegmark’s thought-provoking book will help you join it.” —Professor Stephen Hawking

Dawn of the New Everything: Encounters With Reality and Virtual Reality (Jaron Lanier)-The AI pioneer reminds us again that we're not gadgets, but can use gadgets like AI to reinforce our humanity.

It's Not Dark Yet: A Memoir (Fitzmaurice)-"Written using an eye-gaze computer, this is an unforgettable book about relationships and family, about what connects and separates us as people, and, ultimately, about what it means to be alive."

The Bright Hour (Riggs)-"a book about looking death squarely in the face and saying 'this is what will be'... urges us to live well and not lose sight of what makes us human: love, art, music..."

When Breath Becomes Air (Kalinithi) "At the age of thirty-six, on the verge of completing a decade’s worth of training as a neurosurgeon, Paul Kalanithi was diagnosed with stage IV lung cancer. One day he was a doctor treating the dying, and the next he was a patient struggling to live. And just like that, the future he and his wife had imagined evaporated. When Breath Becomes Airchronicles Kalanithi’s transformation from a naïve medical student “possessed,” as he wrote, “by the question of what, given that all organisms die, makes a virtuous and meaningful life” into a neurosurgeon at Stanford working in the brain, the most critical place for human identity, and finally into a patient and new father confronting his own mortality."

Dying: A Memoir (Taylor)-"At the age of sixty, Cory Taylor is dying of melanoma-related brain cancer. Her illness is no longer treatable: she now weighs less than her neighbor's retriever. As her body weakens, she details the experience—the vulnerability and strength, the courage and humility, the anger and acceptance—of knowing she will soon die. Written in the space of a few weeks, in a tremendous creative surge, this powerful and beautifully written memoir is a clear-eyed account of what dying teaches..."

The Drug Hunters: The Improbable Quest to Discover New Medicines(Kirsch, Ogas)-"Big Pharma conglomerates spend billions on state-of-the-art labs staffed by PhD's to discover blockbuster drugs [but] luck, trial-and-error, risk, and ingenuity are still fundamental to medical discovery..."

Heavens on Earth: The Scientific Search for the Afterlife, Immortality, and Utopia (Shermer)-"concludes with an uplifting paean to purpose and progress and how we can live well in the here-and-now, whether or not there is a hereafter."

Zero K (Don Delillo, fiction) "...Ross is the primary investor in a remote and secret compound where death is exquisitely controlled and bodies are preserved until a future time when biomedical advances and new technologies can return them to a life of transcendent promise... 'We are born without choosing to be. Should we have to die in the same manner? Isn’t it a human glory to refuse to accept a certain fate?'”

Doctors, by Anne Sexton

They work with herbs
and penicillin.
They work with gentleness
and the scalpel.
They dig out the cancer,
close an incision
and say a prayer
to the poverty of the skin.
They are not Gods
though they would like to be;
they are only human
trying to fix up a human.
Many humans die.
They die like the tender,
palpitating berries
in November.
But all along the doctors remember:
First do no harm.
They would kiss if it would heal.
It would not heal.

If the doctors cure
then the sun sees it.
If the doctors kill
then the earth hides it.
The doctors should fear arrogance
more than cardiac arrest.
If they are too proud,
and some are,
then they leave home on horseback
but God returns them on foot.

“Doctors” by Anne Sexton from The Awful Rowing Toward God. © Houghton Mifflin, 1975. WA

Bioethics

Sunday, June 6, 2021

Alzheimer’s Drug Poses a Dilemma for the F.D.A.

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	Julian Baggini (@microphilosophy)
1/19/18, 4:22 AM Transhumanism explained a 2.5 minute animation. @bbcideas bbc.com/ideas/videos/h…

	Five Books (@five_books)
Epidemiology is as old as Hippocrates. The Chinese experimented with immunisation in 1000 BC. buff.ly/2fMuxOw == More 5 books recommendations on health... == 5 books: genetics... genes...